Eli Lilly’s COVID-19 Antibody Treatment Approved for Emergency Use

November 10, 2020 - FDA recently issued an emergency use authorization for Eli Lilly & Company’s COVID-19 antibody treatment for use in mild to moderate coronavirus in adults and pediatric patients.

The emergency use authorization allows healthcare providers to administer a single-dose of bamlanivimab, or LY-CoV555, in infected patients 12 years of age or older as long as they weigh at least 88 pounds. The authorization also states that the treatment be administered to patients  who are at risk for severe COVID-19 or hospitalization. This includes patients 65 years of age or older with underlying medical conditions. 

But the FDA did not authorize the antibody treatment for use in hospitalized patients or patients who require oxygen therapy due to the virus. 

The authorization also requires that fact sheets containing important information about LY-CoV555 usage be made available to healthcare providers and patients, including dosing information and potential side effects of the drug. 

“As illustrated by today’s action, the FDA remains committed to expediting the development and availability of potential COVID-19 treatments and providing sick patients timely access to new therapies where appropriate, while at the same time supporting research to further evaluate whether they are safe and effective,” FDA Commissioner Stephen M. Hahn, MD, said in the announcement. 

“Through our Coronavirus Treatment Acceleration Program, the FDA continues to work around the clock and use every tool at our disposal toward these efforts,” Hanh added.

Eli Lilly developed the lead COVID-19 antibody treatment in collaboration with AbCellera. The companies developed the treatment in three months after AbCellera and National Institute of Allergy and Infectious Diseases (NIAID) identified it from a blood sample taken from one of the first US patients who recovered from COVID-19. 

FDA based its emergency use authorization on available evidence from the Phase 2 BLAZE-1 trial that evaluated 465 non-hospitalized COVID-19 patients.

Overall, patients treated with LY-CoV555 showed reduced viral load and rates of symptoms and hospitalization. Specifically, LY-CoV555 reduced coronavirus-related hospitalizations or emergency room visits in patients within 28 days after treatment compared to a placebo group. 

For patients at high risk for disease progression, hospitalizations and emergency room visits occurred in 3 percent of patients treated with LY-CoV555, compared to 10 percent of patients treated with placebo. 

"The BLAZE-1 data show bamlanivimab, when given early in the disease course, may help patients clear the virus and reduce COVID-related hospitalizations, supporting our belief that neutralizing antibodies can be an important therapeutic option for patients fighting this virus," Daniel Skovronsky, MD, PhD, Eli Lilly’s chief scientific officer and president of Lilly Research Laboratories, said in a press release.

Based on the positive results from the Phase 1 trial, Eli Lilly launched the Phase 3 BLAZE-2 clinical trial evaluating LY-CoV555 at the beginning of August. NIAID and the COVID-19 Prevention Network (CoVPN), as well as multiple long-term care facilities, are also supporting the trial.

The study will enroll nearly 2,500 participants from facilities that have had a recently diagnosed case of COVID-19 and are at a high risk of exposure.

It will evaluate the efficacy and safety of a single dose of LY-CoV555 for the prevention of COVID-19 and uncover if the antibody reduces the rate of COVID-19 over four weeks and complications of the virus through eight weeks. 

HHS and the Department of Defense (DoD) already have plans to purchase the first doses of LY-CoV555. The federal departments announced an agreement with Eli Lilly in October.

The doses of LY-CoV555 will become available for patient care if FDA authorizes use of the therapeutic, following the agency guidance. 

The government-purchased doses of the antibody would also become available to US citizens at no cost, per the agreement with Eli Lilly. But HHS noted that healthcare professionals could charge for administering the medicine.